MedImmune has a position available in the Regulatory Sciences and Strategy group within the Analytical Biotechnology Department at Cambridge, UK European Headquarters. This role will mentor, train and development Analytical CMC Representatives (ACR) to provide effective input on project CMC teams.

Summary of Role

The chosen candidate will:

Play an important role in early drug development by advising and supporting CMC project representatives in analytical requirements

Input on design and Execute a comprehensive ACR education program that aligns existing ACRs with current regulatory and analytical development strategy, and forms a sustainable platform for future ACRs.

Collect metrics to assess effectiveness of education programs .

Execute a formal ACR mentorship program to match new ACRs with experienced ACRs.

Preparation of project summaries and other metrics according to defined analytical requirements at each stage of project progression.

Provide feedback to ACR of performance.

Provide support to Regulatory Sciences and Strategy initiatives in the form of technical expertise and coordination.

Function as Analytical CMC lead for certain project s as required.

Your previous experience will include:

Broad scientific awareness, regulatory and analytical skills for development of biologics, supporting the design/implementation of projects in close co-ordination with Project Management and the Regulatory Sciences and Strategy group.

Ability to interpret data and advice routes of action, advice and train others, effectively trouble shoot, assist in reporting and team presentations with clear effective communication to ensure project goals are achieved